United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 1995_register executive 2010-09-25 article Part VII Rules and Regulations D09002ee1be05ccf3 D09002ee1be05cdcd United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is amending its food additive regulations to establish a process for determining when the likelihood or extent of migration to food of a substance used in a food-contact article is so trivial as not to require regulation of the substance as a food additive. Although still a ``food additive,'' a substance exempted from regulation under this process will not be required to be the subject of a food additive listing regulation. Under this process, information about the proposed use of the substance will undergo an abbreviated review by FDA, as opposed to the extensive review normally required for food additives. This final rule also lists the criteria that FDA will use in its review in deciding whether it is necessary to regulate the use of a substance as a food additive and identifies the types of data that it will need to make this determination. 60 FR 36582 https://www.govinfo.gov/app/details/FR-1995-07-17/95-17435 95-17435 fr17jy95-21 4160-01-P Docket Nos. 77P-0122 and 92N-0181 https://www.govinfo.gov/app/details/FR-1995-07-17/95-17435 https://www.govinfo.gov/content/pkg/FR-1995-07-17/html/95-17435.htm https://www.govinfo.gov/content/pkg/FR-1995-07-17/pdf/95-17435.pdf 15 p. 36582 36596 60 FR 36582 Title 21 Part 21 CFR Part Title 21 Part 170 21 CFR Part 170 Title 21 Part 171 21 CFR Part 171 Title 21 Part 174 21 CFR Part 174 Title 21 Part 25 21 CFR Part 25 Title 21 Part 5 21 CFR Part 5 Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles; Federal Register Vol. 60, Issue RULE 95-17435 VII DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket Nos. 77P-0122 and 92N-0181 4160-01-P 95-17435 Final rule.

The Food and Drug Administration (FDA) is amending its food additive regulations to establish a process for determining when the likelihood or extent of migration to food of a substance used in a food-contact article is so trivial as not to require regulation of the substance as a food additive. Although still a ``food additive,'' a substance exempted from regulation under this process will not be required to be the subject of a food additive listing regulation. Under this process, information about the proposed use of the substance will undergo an abbreviated review by FDA, as opposed to the extensive review normally required for food additives. This final rule also lists the criteria that FDA will use in its review in deciding whether it is necessary to regulate the use of a substance as a food additive and identifies the types of data that it will need to make this determination.

August 16, 1995. Edward J. Machuga, Center for Food Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3085. Vol. 60, no. 136 Office of the Federal Register, National Archives and Records Administration 1995-07-17 continuing daily deposited born digital 307 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1995-07-17 P0b002ee180a8753f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr17jy95 https://www.govinfo.gov/app/details/FR-1995-07-17 https://www.govinfo.gov/content/pkg/FR-1995-07-17/pdf/FR-1995-07-17.pdf fdlp 36339 36634 DGPO 2010-09-25 2023-05-07 FR-1995-07-17 machine generated eng FR FR-1995-07-17 60 136